BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    D.O.R.C. Disposable Cryo Probe

    K Number: K160591 · Decision Jan 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    4
    Review Days
    328

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    Basic Information

    Device Name
    D.O.R.C. Disposable Cryo Probe
    K Number
    K160591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dutch Ophthalmic Research Center International BV
    Date Received
    March 1, 2016
    Decision Date
    January 23, 2017
    Product Code
    HRN
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRN Unit, Cryophthalmic, Ac-Powered

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